NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. IN THE SPIRIT OF WALTER R. CLEMENT BS., MS, MBA. HARVEY JENKINS MD, PH.D., IN THE SPIRIT OF C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., EVELYN J. CLEMENT, WALTER F. WRENN III., MD., JULIE KILLINGSWORTH, RENEE BLARE, RPH, DR. TERENCE SASAKI, MD LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA,AISHA GARDNER, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

“..Born Free Yet Bound and Shackled by Department of Justice Glenn Leon’s and Dr. Tim King’s Machines of Loving Grace and Slavery with Extra Steps..” 

Background

The DEA’s War on Pain Doctors

“A CASE OF SYSTEMIC GENOCIDE“

So unethical to ignore Australia’s 28 studies over 24 million people and that human beings are different here than they are anywhere else. It’s the biggest scam ever seen but it involves sadistic♿️torture so it’s also an attack and an assault and a genocide. pic.twitter.com/JX1Mg27pdw

— BilkedToTheBrink (@Bilked2TheBrink) January 19, 2025

The 2005, Cato Institute policy analysis paper by Ronald T. Libby examines the detrimental effects of the Drug Enforcement Administration’s (DEA) aggressive crackdown on prescription painkillers, particularly OxyContin.

The paper argues that the DEA’s actions, fueled by media exaggeration and flawed data, have led to the undertreatment of chronic pain by scaring physicians away from prescribing opioids.

Libby highlights the crucial distinction between addiction and physical dependence, arguing that the DEA’s approach conflates the two, resulting in unjust prosecutions of doctors and severe hardship for patients.

The paper further criticizes the DEA’s methods, including its reliance on questionable data and aggressive investigative tactics that harm the doctor-patient relationship. Finally, the report suggests that the DEA should focus on addressing the black market distribution of drugs rather than prosecuting physicians.

FROM THE LIBBY REPORT:

“In 2000 and 2001, the Department of Justice, which administers the DEA, gave the agency a highly critical rebuke and asserted that the Drug Enforcement Agency’s goals were not consistent with the president’s federal National Drug Control Strategy.40 The DEA would need to find a new front for the War on Drugs, one that could produce tangible, measurable results.

@need2beseen1

#Need2BeSeen1 Kathleen Melcher’s story as a patient in pain. #WeR1 #StrengthInNumbers #fyp #pain #opioids #fibromyalgia #disease #chronicpain #story #storytime #dea #cdc #ama #doj

♬ original sound – Need2BeSeen

In 2001, the DEA had already announced a major new anti-drug campaign: the OxyContin Action Plan.42 The agency underscored the threat of prescription drug abuse by asserting that the number of people who “abuse controlled pharmaceuticals each year equals the number who abuse cocaine—2 to 4 percent of the U.S. population.”43 

Criticism from Congress and the Department of Justice the following year reaffirmed the agency’s determination to crack down on prescription drugs. The OxyContin plan would elevate a legal prescription drug to the status of cocaine and other Schedule II substances.

That shift put pain doc- tors in the DEA’s crosshairs, as susceptible to investigation as conventional drug dealers. The OxyContin plan would elevate a legal, prescrip- tion drug to the status of cocaine and other Schedule II substances. That shift put pain doc- tors in the DEA’s crosshairs, as susceptible to investigation as conventional drug dealers. 

The OxyContin Action Plan bore a remarkable resemblance to the Harrison Act in that it enabled the federal government to prosecute physicians who prescribed an otherwise legal narcotic drug due to unfounded fears of a “dope menace” sweeping the country.

DEA commissioner Asa Hutchinson described the nonmedical use of OxyContin as a deadly new rug epidemic beginning in Appalachia and spreading to the East Coast and Midwest, infecting suburban, urban, and rural neighborhoods across the country:

This was the first time that the DEA had grouped a legal prescription drug with illicit drugs, though it wouldn’t be the last. Government officials like Hutchinson have gone on to make frequent public statements putting OxyContin in close rhetorical proximity to cocaine, heroin, and other drugs with a proven record for generating public fear.

During congressional testimony in April 2002, Hutchinson explained the necessity for renewed vigilance in the War on Drugs, and why the new front against prescription painkillers was necessary.

Justifying the OxyContin Campaign

In an effort to justify its national campaign against OxyContin, the DEA contacted 775 medical examiners from the National Association of Medical Examiners in 2001 and instructed them to report “OxyContin-related deaths” for 2000 and 2001. (48) On the basis of those reports, the DEA subsequently announced 464 “OxyContin-related deaths” over those two years. (49)

But the conclusions the DEA drew from this data are significantly flawed.

First, the DEA’s criteria for “OxyContin- related deaths” are problematic. There are 58 pain relief drugs that contain oxycodone. OxyContin is simply one of three single-entity, long-acting oxycodone drugs.

@jonelleelgaway

What happened at my appt wirh the neurologist at Duke. #fyp #fypシ #duke #neurologist #seizures #epilepsy #cpps

♬ original sound – Jonelle Elgaway

There are numerous other less potent, short-acting, oxy- condone drugs, such as Percocet, Percodan, and Roxicet, that also contain non-narcotic pain relievers such as aspirin or Tylenol. OxyContin is Purdue Pharma’s brand name drug. It’s popular because it provides long-acting relief from pain for up to 12 hours, which enables pain sufferers to sleep through the night.

Since there is no chemical test to distinguish OxyContin from the other oxycodone drugs, it is difficult to see how the DEA could definitively assert that a death attributable to oxycodone is due to OxyContin and not other short-acting oxycodone drugs. Nevertheless, the DEA counts as an “OxyContin-related death,” any death in which oxycodone is detected without the presence of aspirin or Tylenol. (50)

Second, if an OxyContin tablet is found in the gastrointestinal tract of a deceased person, the DEA labels it an “OxyContin-verified death,” regardless of other circumstances.

Even more problematic, if investigators find OxyContin pills or prescriptions at a crime scene, or a family member or witness merely mentions the presence of OxyContin, the death is also confirmed as “OxyContin-veri- fied.”(51) Obviously the mere presence of OxyContin in the system of the deceased, or the mere mention of the drug by friends or family members is far from verification that OxyContin—either alone or in conjunction with other factors—actually caused a premature death.

Third, overdose victims tend to have multiple drugs in their bodies.52 Approximately 40 percent of the autopsy reports of OxyContin-related deaths showed the presence of Valium-like drugs. Another 40 percent contained a second opiate, such as Vicodin, Lortab, or Lorcet, in addition to oxycodone.

Thirty percent showed an antidepressant such as Prozac, 15 percent showed cocaine, and 14 percent indicated the presence of over-the-counter antihistamines or cold medications. Deaths like those could be the result of any of the drugs present, drugs working in combination, or one or more drugs plus the effects of other conditions, such as illness or disease.

Indeed, the March 2003 issue of the Journal of Analytical Toxicology found that of the 919 deaths related to oxycodone in 23 states over a three-year period, only 12 showed confirmed evidence of the presence of oxycodone alone in the system of the deceased.(53) 

About 70 percent of the deaths were due to “multiple drug poi- soning” of other oxycodone-containing drugs in combination with Valium-type tranquiliz- ers, alcohol, cocaine, marijuana, and/or other narcotics and anti-depressants.(54) 

That is strong evidence that many of the deaths attributed to OxyContin by government officials are not the result of unknowing pain patients who grew addicted and overdosed but of habitual drug users who may have used the drug with any number of other sub- stances, any one of which could have contributed to overdose and death.”

_______________________________________________________/

41. “Review of the Drug Enforcement Administra- tion’s (DEA) Control of the Diversion of Controlled Pharmaceuticals,” The Drug Enforcement Administration, September 2002, http:// http://www.usdoj.gov/oig/inspection/DEA/0210/ Memo.htm.

42. U.S. Department of Justice, Drug Enforcement Administration, “Action Plan to Prevent the Diversion and Abuse of OxyContin,” 2001; U.S. Department of Justice, Drug Enforcement Administration, “DEA-Industry Communicator: Oxy-Contin Special,” vol. 1.

43. Ibid.

44. Ibid.

45. Josh White and Marc Kaufman, “U.S. Compares Va. Pain Doctor to ‘Crack Dealer,’” Washington Post, September 30, 2003, p. B-3.

46. Statement of Asa Hutchinson, administrator, Drug Enforcement Administration before the United States Senate Caucus on International Narcotics Control, Executive Summary, April 11, 2002, http://www.dea.gov/pubs/cngrtest/ct041102p.html.

47. Ibid, pp. 1, 3–4.

48. U.S. Department of Justice, Drug Enforcement Administration, Diversion Control Program, “Summary of Medical Examiner Reports on Oxycodone-Related Deaths,” May 16, 2002, www. deadiversion.usdoj.gov/drugs_concern/oxy codone/oxycotin7.htm.

49. Ibid., p. 4.
50. Ibid., pp. 1–2. 51. Ibid., p. 2.
52. Ibid.

53. Cone et al., “Oxycodone Involvement in Drug Abuse Deaths: A DAWN-Based Classification Scheme Applied to an Oxycodone Postmortem Database Containing over 1000 Cases,” Journal of Analytical Toxicology 27, no. 2 (March 2003): 57–67. This study was funded by Purdue Pharma, manufacturer of OxyContin, but was subjected to the normal peer review process.

INTRODUCTION

For more than a decade, the US and international public has been hearing that prescription opioid pain relievers are always and forever a “BAD THING” — and that doctors and Big Pharma companies are supposedly responsible for an epidemic of addiction and drug overdose-related deaths.

The government claims CVS knowingly prioritized profits over patient safety, creating unsafe working conditions that led to pharmacists filling prescriptions without proper due diligence.  This is a consolidated complaint filed by the United States against CVS Pharmacyand its subsidiaries.  

The complaint alleges that CVS routinely filled invalid prescriptions for controlled substances, violating the Controlled Substances Act (CSA) and the False Claims Act (FCA).  Numerous examples of specific prescriptions and prescribers involved in the alleged illegal activity are provided as evidence. 

The provided text centers on a nationwide lawsuit against CVS Pharmacy. The suit alleges that the company knowingly dispensed controlled substances illegally, violating the Controlled Substances Act and the False Claims Act. It seeks substantial civil penalties, injunctive relief to prevent future violations, and restitution for funds improperly obtained from federal healthcare programs. 

Our counterarguments criticize the government’s approach to the opioid crisis, citing flawed data, algorithmic bias in enforcement, and unduly restrictive policies harming patients and physicians.

STATEMENT

The question here is the Rule of Law. It is the most fundamental concept of our country; without it, our society crumbles. Most importantly, these violations and failures to adhere to this (most) sacred fundamental concept then permit any government agency to seize anything they want unchecked, based on their own manufactured rules and misinterpretation of laws and medical procedures/ guidelines, creating their science and facts. 

Specifically, misidentifying the dosages and purposes of legally and medically prescribed FDA-approved Narcotic Analgesic medications, “having a useful and legitimate medical purpose,” to be illegitimate. Congress determined Federal law enforcement agencies are unqualified to determine whether drugs “have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.” 21 U.S.C. § 801(1). 

These counterarguments further highlight the use of biased algorithms in Prescription Drug Monitoring Programs (PDMPs) and question the validity of the CDC’s opioid prescribing guidelines. 

The debate involves the ethical implications of AI in healthcare and law enforcement, advocating for a more evidence-based and human-centered approach.

DEA OVERREACH, CVS PHARMACY INCOMPETENCE, AND INDIFFERENCE TORTURE LUNG CANCER PATIENT

Justice Department Files Nationwide Lawsuit Alleging CVS Knowingly Dispensed Controlled Substances in Violation of the Controlled Substances Act and the False Claims Act

Wednesday, December 18, 2024

For Immediate Release

Office of Public Affairs

In a civil complaint unsealed today in Providence, Rhode Island, the Justice Department alleges that CVS Pharmacy Inc. and various subsidiaries (collectively, CVS) filled unlawful prescriptions in violation of the Controlled Substances Act (CSA) and sought reimbursement from federal healthcare programs for unlawful prescriptions in violation of the False Claims Act (FCA). CVS is the country’s largest pharmacy chain, with more than 9,000 pharmacies across the United States.

The government’s complaint alleges that, from Oct. 17, 2013, to the present, CVS knowingly filled prescriptions for controlled substances that lacked a legitimate medical purpose, were not valid, and/or were not issued in the usual course of professional practice. Among the large number of unlawful prescriptions that CVS allegedly filled were prescriptions for dangerous and excessive quantities of opioids, early fills of opioids, and “trinity” prescriptions, an especially dangerous and abused combination of drugs made up of an opioid, a benzodiazepine and a muscle relaxant. CVS also allegedly filled large quantities of prescriptions for controlled substances written by prescribers it knew to be engaged in “pill mill practices” — that is, prescribers who issue large numbers of controlled substance prescriptions without any medical purpose. According to the complaint, CVS ignored substantial evidence from multiple sources, including its own pharmacists and internal data, indicating that its stores were dispensing unlawful prescriptions.

The complaint alleges that CVS’ violations resulted from corporate-mandated performance metrics, incentive compensation, and staffing policies that prioritized corporate profits over patient safety. CVS set staffing levels far too low for pharmacists to both meet their performance metrics and comply with their legal obligations. CVS also allegedly deprived its pharmacists of crucial information (including by, for example, preventing pharmacists from warning one another about certain prescribers) that could have reduced the number of unlawful prescriptions filled. The complaint alleges that CVS’ actions helped to fuel the opioid crisis and that, in some particularly tragic instances, patients died after overdosing on opioids shortly after filling unlawful prescriptions at CVS.

“Our complaint alleges that CVS repeatedly filled controlled substance prescriptions that were unlawful and pressured its pharmacists to fill such prescriptions without taking the time needed to confirm their validity,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The practices alleged contributed to the opioid crisis and opioid-related deaths, and today’s complaint seeks to hold CVS accountable for its misconduct.”

A SHORT PODCAST BRIEFING OUTLINING THE CASE OF UNITED STATES VS CVS. CLICK HERE TO LISTEN

The document displayed below is a consolidated complaint filed by the United States against CVS Pharmacy, alleging violations of the Controlled Substances Act (CSA) and the False Claims Act (FCA).

The complaint asserts that CVS routinely filled invalid prescriptions for controlled substances, contributing to the opioid crisis.

Evidence presented includes internal CVS documents, pharmacist testimony, and examples of prescriptions filled for patients who later died from overdoses. CVS is accused of prioritizing profit over patient safety by creating unsustainable work conditions that prevented pharmacists from properly vetting prescriptions.

The government seeks substantial monetary penalties and injunctive relief to prevent future violations.

COMPREHENSIVE ANALYSIS OF UNITED STATES ex rel. Hillary Estright v. CVS Pharmacy et.al

“Opioid deaths remain a scourge on communities across Rhode Island and the nation, robbing families of loved ones and leaving a path of devastation in their wake,” said U.S. Attorney Zachary A. Cunha for the District of Rhode Island. “This lawsuit alleges that CVS failed to exercise its critical role as gatekeeper of dangerous prescription opioids and, instead, facilitated the illegal proliferation of these highly addictive drugs, including by pill mill prescribers. When corporations such as CVS prize profits over patient safety and overburden their pharmacy staff so that they cannot carry out the basic responsibility of ensuring that prescriptions are legitimate, we will use every tool at our disposal to see that they answer for it.”

The government alleges that by knowingly filling unlawful prescriptions for controlled substances, CVS violated the CSA and, where CVS sought reimbursement from federal healthcare programs, also violated the FCA. The complaint alleges that CVS’s actions helped to fuel the opioid crisis. If CVS is found liable, it could face civil penalties for each unlawful prescription filled in violation of the CSA and treble damages and applicable penalties for each prescription reimbursed by federal healthcare programs in violation of the FCA. The court also may award injunctive relief to prevent CVS from committing further CSA violations, including ordering appropriate changes to corporate compliance programs and policies.

“When lives are destroyed or lost to opioid abuse, it doesn’t matter if the supplier is a street-level dealer, a pill mill, or a nationwide corporation,” said U.S. Attorney Jessica D. Aber for the Eastern District of Virginia. “Our laws regarding the dispensing of opioids and other controlled substances are clear and apply to everyone. We will pursue whatever legal action is necessary to stop any enterprise, regardless of size, that places profit over the safety of our citizens.”

“CVS is alleged to have dispensed large amounts of highly addictive opioid medications to persons they knew had no medical need for them,” said Administrator Anne Milgram of the Drug Enforcement Administration (DEA). “Simply put, they put profits over their obligation to keep their customers safe. A pharmacy is the final step in the pharmaceutical distribution process that is in place to keep customers safe. In the fight against the opioid epidemic, DEA will continue to be relentless in holding those accountable who violate our drug laws and place our communities in danger whether they are a criminal cartel or large pharmacy chain.”

“Pharmacies and pharmacists are critical partners to ensure controlled substances are dispensed lawfully and safely to the public,” said Deputy Inspector General Christian J. Schrank of the Department of Health and Human Services Office of Inspector General (HHS-OIG). “HHS-OIG is committed to holding individuals and entities that dispense these controlled substances improperly and without legitimate medical purpose accountable.”

“Protecting TRICARE, the healthcare system for military members and their dependents, is a top priority for the Department of Defense Office of Inspector General Defense Criminal Investigative Service (DCIS),” said Special Agent in Charge Patrick J. Hegarty of the DCIS Northeast Field Office. “Today’s filing demonstrates DCIS’ ongoing commitment to partner with the Department of Justice and our law enforcement partners to investigate health care providers that submit false claims to TRICARE and put its beneficiaries at risk.”

Whistleblower Hillary Estright, who previously worked for CVS, filed an action on Oct. 17, 2019, under the qui tam provisions of the FCA. Those provisions authorize private parties to sue on behalf of the United States for false claims and share in any recovery. The Act permits the United States to intervene and take over such lawsuits, as it has done here. The case is captioned United States ex rel. Estright v. Health Corporation, et al., No. 1:22-cv-222 (D.R.I.).

The United States’ intervention in this matter underscores the government’s commitment to combating health care fraud. One of the most powerful tools in this effort is the FCA. Tips and complaints from all sources about potential fraud, waste, abuse and mismanagement can be reported to HHS, at 800-HHS-TIPS (800-447-8477).

The DEA’s Office of Diversion Control, Washington, D.C. Division, HHS-OIG and DCIS investigated the case. The U.S. Attorneys’ Offices for the Southern District of California and Northern District of Ohio, DEA’s Office of Chief Counsel, Office of Personnel Management, Department of Labor Office of Inspector General, U.S. Postal Service Office of Inspector General and FBI provided substantial assistance in the investigation.

Assistant Directors Amy L. DeLine and C.B. Buente, Senior Litigation Counsel Donald Lorenzen and Trial Attorneys Benjamin Cornfeld and Amanda K. Kelly of the Civil Division’s Consumer Protection Branch; Trial Attorneys Claire L. Norsetter, Joshua Barron and Megan F. Engel of the Civil Division’s Commercial Litigation Branch, Fraud Section; First Assistant U.S. Attorney Sara M. Bloom and Assistant U.S. Attorneys Kevin Love Hubbard and Rachna Vyas for the District of Rhode Island; Assistant U.S. Attorneys Clare Wuerker and John Beerbower for the Eastern District of Virginia; Assistant U.S. Attorneys Sydney Spector and Tracy Weinstein for the District of Hawaii; and Assistant U.S. Attorneys James Gillingham and Adrian Garcia for the Eastern District of Texas are litigating the enforcement action.

The claims asserted against the defendants are allegations only. There has been no determination of liability.

ARUGUMENT

HOW LIBBY REPORT OF 2005 UNDERMINES DEA CASE AGAINST CVS et al., 2024, THE BILLION DOLLAR SETTLEMENT AGAINST Purdue Pharma,THE SACKLER FAMILY AND THE AUGUST 29, 2019 LOOTING RAID ON PRONTO PHARMACY LLC, et al.

Painkillers and the Law: A Study Guide
Short-Answer Questions (2-3 sentences each)

View the complaint here. 

What are the societal costs of untreated pain, according to this study?
According to the study, what is the primary reason many physicians are hesitant to adequately treat pain?
When was the first federal law criminalizing the non-medical use of drugs enacted, and what was it called?
According to this policy analysis, what prompted the DEA to shift its focus to prescription drugs?
Describe the DEA’s OxyContin Action Plan. What was its purpose, and what were some of its key components?
What flaws does this study identify with the DEA’s attempts to justify the OxyContin Campaign?
What is the distinction between “physical dependence” and “addiction” according to this study, and why is this distinction important?
How did the Orlando Sentinel series on OxyContin impact public perception and law enforcement efforts regarding the drug?
How is the DEA’s Diversion Control Program funded, and what are some of the ethical concerns raised about this funding mechanism?
Describe some of the “red flags” used by law enforcement to identify doctors suspected of illegally diverting prescription painkillers. What are some of the problems associated with relying on these red flags?

Answer Key
The study argues that untreated pain leads to needless suffering and damages, including broken marriages, alcoholism and family violence, absenteeism and job loss, depression, and suicide.
The study suggests that physicians are increasingly hesitant to treat pain due to the government’s aggressive prosecution of pain doctors accused of overprescribing narcotics. This fear of legal repercussions deters many from entering the field or providing adequate pain relief.
The Harrison Act of 1914 was the first federal law to criminalize the non-medical use of drugs. This act outlawed the non-medical use of opium, morphine, and cocaine.
The study argues that criticism from Congress regarding the DEA’s lack of measurable success in reducing the illegal drug supply led the agency to shift its focus to prescription drugs. Prescription drug abuse was deemed a tangible, measurable front in the War on Drugs.
The DEA’s OxyContin Action Plan, launched in 2001, aimed to combat the perceived epidemic of prescription drug abuse, particularly focusing on OxyContin. Key components included increased investigations and prosecutions of medical professionals, public relations campaigns linking OxyContin to illicit drugs, and collaboration with state and local law enforcement through task forces.
The study critiques the DEA’s reliance on “OxyContin-related deaths,” arguing that the criteria are too broad, often simply indicating the presence of oxycodone without establishing OxyContin as the specific cause of death. Additionally, the study challenges the DEA’s risk assessment, highlighting the relatively low number of deaths compared to NSAID-related fatalities.
Physical dependence refers to the body’s physiological adaptation to a drug, resulting in withdrawal symptoms upon cessation. Addiction, on the other hand, encompasses a compulsive drug-seeking behavior and a loss of control despite negative consequences. This distinction is crucial because it differentiates legitimate pain management with opioids from drug abuse.
The Orlando Sentinel series, while later discredited, significantly contributed to nationwide OxyContin fears. The series, which reported high numbers of OxyContin-related deaths, fueled public perception of the drug as dangerous and prompted increased law enforcement efforts in Florida, making it one of the most difficult states for pain patients to access treatment.

The DEA’s Diversion Control Program is primarily funded through licensing fees charged to doctors, manufacturers, pharmacists, and wholesalers of narcotics. The study criticizes this self-financing mechanism as it makes the program largely unaccountable to congressional oversight and creates a system where doctors finance investigations against themselves or their colleagues.

The DEA uses “red flags” – often circumstantial evidence – to identify doctors potentially diverting painkillers. These include factors like long patient wait times, out-of-state licenses, short visits, and high narcotics prescriptions. The study argues that these red flags are problematic as they can be consistent with legitimate pain management practices. They give investigators without medical training the power to interpret medical decisions, leading to potentially unjust prosecutions of legitimate physicians.
Essay Questions
Discuss the historical context of drug regulation in the United States, drawing parallels between the Harrison Act of 1914 and the DEA’s recent crackdown on prescription painkillers.
Analyze the ethical dilemmas faced by physicians prescribing opioid medications for pain management in the current legal and social climate.
Critically evaluate the DEA’s efforts to combat prescription drug abuse, considering their effectiveness, unintended consequences, and impact on pain patients.
To what extent has media coverage contributed to public anxieties surrounding prescription painkillers? Discuss the role of specific media examples, such as the Orlando Sentinel series.
Analyze the potential conflict of interest inherent in the DEA’s self-financed Diversion Control Program. Discuss the ethical and practical implications of this funding structure.
Glossary of Key Terms
Chronic pain: Pain that persists for an extended period, typically lasting longer than six months.
Acute pain: Pain that is typically of short duration and often associated with a specific injury or condition.
Narcotics: A class of drugs that act as central nervous system depressants, producing analgesic (pain-relieving) and sedative effects.

Opioids: A subclass of narcotics derived from opium or synthetically produced with similar properties. Examples include morphine, oxycodone, and heroin.
OxyContin: A brand name for a long-acting, controlled-release formulation of oxycodone, an opioid painkiller.
Diversion: The illegal channeling of prescription drugs from legal sources to the black market.
Physical dependence: A physiological adaptation to a drug, characterized by withdrawal symptoms upon cessation of use.
Addiction: A chronic, relapsing disorder characterized by compulsive drug seeking and use despite harmful consequences.
Pseudoaddicts: Patients with legitimate pain conditions who exhibit drug-seeking behaviors due to inadequate pain management, mistakenly labeled as addicts.
Red flags: Circumstantial indicators used by law enforcement to identify potential illegal activity, which may be misinterpreted in the context of medical practice.
Asset forfeiture: A legal process that allows law enforcement to seize assets believed to be connected to criminal activity, even before a conviction is secured.

USE ALL TOOLS: A SYNOPSIS OF AUSA GLENN LEON’S TOOLS AND MACHINES OF LOVING GRACE

1

AMERICA’S CLOCKWORK ORANGE AND DOJ/DEA’S GLORIOUS PSYCHOPATH AUSA GLENN LEON PART-2., “A DEEP UNDERSTANDING”

2

THE LEARNING POST: MORPHINE MILLIGRAM EQUIVALENT(MME), SIGNIFICANT LIMITATIONS, UNDERSTANDING THE FLAWS: (Clement’s Principles of Health Law No.1: Panopticonism coupled with The Principles of Bartolini’s Law(of B-S) permits The Practice of Medicine and Criminality To Be One in The Same)

3

AMERICA’S CLOCKWORK ORANGE ALL WATCHED OVER BY THE US. DEPARTMENT OF JUSTICE MACHINES OF LOVING GRACE: AUSA GLENN LEON’S AMERICAN NIGHTMARE: PART-1

4

“USE ALL TOOLS:” THEN SHOW US THE ALGORITHMS, WHY IS AG MERRICK GARLAND, DEA DIRECTOR ANN MILGRAM, AUSA GLENN LEON AND CDC NOT TURNING OVER INFORMATION REQUESTED IN OUR FOIA DEMANDS: “DOCTORS WAGE WAR ONTO THE DEA”

SICKEL CELL DISEASE:A PAIN THAT LAUGHS AT MORPHINE

5: Through artistic renderings, photos taken during his life, and historical medical documents that marked a turning point in science, we pay tribute to the enduring legacy of Dr. Walter Clement Noel, DDS, the first Sickle Cell patient. His story is more than a chapter in medical textbooks; it’s a narrative of perseverance, achievement, and the indomitable will to fulfill one’s dreams against all odds. Born in the lush landscapes of Grenada in 1884, Noel’s dreams led him across the sea to the United States, where he pursued a career in dentistry. Despite facing relentless health challenges, Noel’s spirit remained unbreakable.

D.E.A.’S ANNE MILGRAM, DOJ’S AUSA GLENN LEON, POSITIVE FEED BACK LOOP AND THE MURDER OF SICKLE CELL ADVOCATE BRITTANY HIGHTOWER; “SUICIDE PREVENTION AND DEATH IS THE NEW PAIN MANAGEMENT”

6

D.E.A.’s ANN MILGRAM, D.O.J’s AUSA GLENN LEON ARE DESTROYING THE BEST DOCTORS IN AMERICA, DR’s RUAN, NORRIS, ANAND, WRENN, HANSEN, LEWIS, BRIZUELA, et al., “OUTSIDE THE USUAL PRACTICE OF MEDICINE”

7

BEYOND THE GAVEL: DOJ FRAUD CHIEF AUSA GLENN LEON VS. DR. JOHN LOCKE,MD., “RETHINKING PROSECUTION OF MEDICAL MAVERICKS IN THE AMERICAN LEGAL ARENA”

8

WHY HARVEY JENKINS MD., CRIMINAL CASE MUST BE DISMISSED: PETER “THE GREAT PETE,” PISCHKE, THE HAPPY WARRIOR PODCAST: OKLAHOMA PAIN PATIENTS FIGHT BACK TO LAW CHANGE

9

CATALOG-3: AUSA GLENN LEON SERIES “MACHINES OF LOVE AND GRACE AMERICA’S CLOCKWORK ORANGE: THE FEDERAL WAR ON MEDICINE

CLICK HERE TO SEE AND LISTEN: DR. MARK IBSEN, MD DEMONSTRATES PHARMACISTS ABUSES AND THE RESULTS OF WITHHOLDING PATIENT PAIN CARE USING “CORRESPONDING IRRESPONSIBILTY” BY ENTERING NOTHING INTO WRITING

10.

EXPOSING SADISTIC PHARMACISTS INHUMAN BEHAVIORS USE OF CORRESPONDING IRRESPONSIBILITY OF INDIFFERENCE, BARBARISM AND TORTURE: “RULINGS FROM THE COUNTER,” WHERE BOARDS OF PHARMACY HAVE SANCTIONED A SYSTEM OF CIRCLING THE DRAIN

SUMMARY

The Libby Cato Report  of 2005 “Treating Doctors as Drug Dealers,” analysis paints a concerning picture of the DEA’s crackdown on prescription painkillers that has continued twenty plus years later.

The 2005 report argues that the United Department of Justice -Drug Enforcement Administration agency’s actions are driven by unfounded fears, flawed data, and a self-serving financial structure, and ultimately result in the denial of essential medical care to millions of pain patients.

These timelines and cast of characters provides a comprehensive overview of the key events and individuals involved in the DEA’s crackdown on prescription painkillers.

It highlights the shift in the D.E.A’s focus, the flawed data and media coverage used to justify their campaign, the aggressive tactics employed against doctors and patients, and the consequences of this approach, including the chilling effect on pain treatment and the erosion of the doctor-patient relationship. 

The Case against CVS, et al. present a complex and concerning picture of the intersection between AI, the opioid crisis, and the criminalization of healthcare.

While well-intentioned, policies based on flawed data and algorithms have created unintended consequences, leading to the under-treatment of pain and the persecution of healthcare providers.

The the United States Department of Justice complaint against CVS et al, lacks merit; it calls for substantial civil penalties, a permanent injunction, and a thorough reform of CVS’s prescription dispensing practices.

However, in the words of CVS Healthcare Pharmacy and the authors of this report the government’s case is nothing but a complete “MONEY GRAB.” 

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THE LIBBY REPORT TIME LINE

This timeline and cast of characters provides a comprehensive overview of the key events and individuals involved in the DEA’s crackdown on prescription painkillers.

It highlights the shift in the DEA’s focus, the flawed data and media coverage used to justify their campaign, the aggressive tactics employed against doctors and patients, and the consequences of this approach, including the chilling effect on pain treatment and the erosion of the doctor-patient relationship.

Cast of Characters

Government Officials & Agencies

• Drug Enforcement Agency (DEA): The federal agency responsible for enforcing drug laws. The DEA shifted its focus to prescription painkillers, particularly OxyContin, in the early 2000s, leading to aggressive investigations and prosecutions of doctors.
• Asa Hutchinson: DEA administrator during the launch of the OxyContin Action Plan. He played a key role in framing the narrative of OxyContin as a dangerous, widely abused drug, comparing it to heroin and cocaine.
• Glen A. Fine: Inspector General of the Department of Justice who questioned the DEA’s focus on illegal drugs and suggested they combat prescription drug abuse.
• Mark Lytle: U.S. Attorney who compared Dr. William Hurwitz to a street-corner crack dealer during his indictment.
• James McDonough: Florida director of drug control who praised the (flawed) Orlando Sentinel series on OxyContin and highlighted Florida’s aggressive actions against doctors.

Doctors

• Dr. William Hurwitz: Virginia pain specialist who was indicted on 60 counts, compared to a “street-corner crack dealer,” and ultimately convicted and sentenced to 25 years in prison despite evidence suggesting his patients deceived him.
• Dr. Russell K. Portenoy: Pain specialist and pioneer in opioid pain therapy who criticized the DEA’s crackdown on pain doctors, arguing it would harm patients in need of pain relief.
• Dr. Frank Fisher: California physician who was falsely accused of murder, fraud, and drug diversion, enduring years of legal battles and asset seizures before being acquitted.
• Dr. John F. Lilly: Orthopedist and pain clinic proprietor investigated for diversion, accused of running a “pill mill.”
• Dr. James Graves: Former Navy flight surgeon convicted on four counts of manslaughter for prescribing oxycodone.
• Dr. Sarfraz Mirza: Convicted of trafficking in OxyContin.
• Dr. Asuncion Luyao: Prosecuted for prescription overdose deaths (case ultimately ended in a mistrial).
• Dr. Eli Schneider: Physician whose assets were seized before any charges were filed, highlighting the practice of asset forfeiture before due process.
• Dr. Ghassan Haj-Hamed: Kentucky physician whose clinic was accused of diversion, forcing him into a settlement with the DEA due to the financial strain of asset seizures.

Other Key Figures

• Doris Bloodsworth: Orlando Sentinel reporter who wrote the widely criticized series on OxyContin deaths, later resigning after the series’ inaccuracies came to light.
• Richard Paey: Florida pain patient with multiple sclerosis who was sentenced to 25 years in prison for possessing a large quantity of pain medication, even though it was for personal use.
• David Brushwood: University of Florida professor of pharmacy and lawyer who criticized the DEA’s shift to aggressive tactics and the breakdown of the previously cordial relationship between law enforcement and medical professionals.
• Detective Dennis M. Luken: Member of the Warren-Clinton Drug Task Force and treasurer of NADDI who advocated for seizing doctors’ assets to bolster law enforcement budgets.

Organizations

• National Association of Medical Examiners: Provided data on “OxyContin-related deaths” to the DEA, which was later criticized for its methodology and interpretation.
• National Association of Drug Diversion Investigators (NADDI): Organization focused on investigating and prosecuting pharmaceutical drug diversion, playing a key role in training law enforcement to target physicians.
• National Association of Attorneys General: Expressed concern about the DEA’s aggressive approach to fighting diversion and its negative impact on pain patients’ access to treatment.

THE LIBBY REPORT BRIEFING SYNOPSIS AND FINDING OF FACTS

Briefing Doc: The DEA’s War on Prescription Painkillers

Source: Ronald T. Libby, Treating Doctors as Drug Dealers: The DEA’s War on Prescription Painkillers, Cato Institute Policy Analysis no. 545, June 16, 2005.

Main Themes:

• The undertreatment of pain in the United States. Libby argues that millions of Americans suffer from undertreated pain due to the government’s aggressive prosecution of doctors who prescribe narcotic painkillers.
• The DEA’s shift in focus from illicit drugs to prescription painkillers. Libby criticizes the DEA’s decision to target pain doctors as part of its “war on drugs”, arguing that it has created a climate of fear that prevents doctors from adequately treating their patients.
• The questionable justification for the DEA’s OxyContin campaign. Libby challenges the DEA’s claims about an “OxyContin epidemic” and argues that their data are flawed and risk assessments are inflated.
• The harmful effects of the DEA’s crackdown on pain management. Libby details the negative impact of aggressive DEA tactics on the doctor-patient relationship, including patient distrust and fear of being labeled an addict.
• The problematic nature of the DEA’s Diversion Control Program. Libby criticizes the program’s self-financing structure and lack of accountability, which he argues incentivizes targeting doctors for asset forfeiture.

Most Important Ideas/Facts:

• Untreated pain is a significant problem: “The American Pain Foundation… puts the number [of Americans suffering from pain] at 75 million—50 million from serious chronic pain (pain lasting six months or more), and an additional 25 million from acute pain caused by accidents, surgeries, and injuries.”
• Fear of prosecution deters doctors from treating pain: “A 2001 study of California doctors found that 40 percent said their fear of an investigation affected how they treated chronic pain.”
• The DEA’s focus on OxyContin mirrors the Harrison Act: “The OxyContin Action Plan bore a remarkable resemblance to the Harrison Act in that it enabled the federal government to prosecute physicians who prescribed an otherwise legal narcotic drug, due to unfounded fears of a ‘dope menace’ sweeping the country.”
• The DEA’s data on OxyContin deaths are misleading: “The DEA counts as an “OxyContin-related death” any death in which oxycodone is detected without the presence of aspirin or Tylenol… Obviously the mere presence of OxyContin in the system of the deceased, or the mere mention of the drug by friends or family members is far from verification that OxyContin… actually caused a premature death.”
• Media hype has contributed to fear of painkillers: “It would be difficult to overstate how much the Sentinel series contributed to nationwide OxyContin fears.” ****
• The DEA’s Diversion Control Program is self-financing and incentivizes targeting doctors: “It is a perverse system that allows law enforcement officials to keep the assets of suspected drug defendants for their own, local police departments.”
• The DEA has lowered its evidentiary standards: “The DEA continues to lower its evidentiary standards, making it nearly impossible for many doctors to determine what is and isn’t permitted.”
• Aggressive DEA tactics damage the doctor-patient relationship: “The DEA’s aggressive investigative procedures poison the doctor-patient relationship from both sides.”
• Doctors are being prosecuted despite lack of evidence of intent to profit: “The DEA now insists that prosecutors do not have to prove a doctor’s malicious intent or desire to profit from narcotics diversion to secure a conviction.”

Key Quotes:

• Dr. Russell K. Portenoy: ““The medical ambiguity is being turned into allegations of criminal behavior… We have to draw a line in the sand here, or else the treatment will be lost, and millions of patients will suffer.””
• Asa Hutchinson: “Hutchinson announced that the DEA would reallocate many of its resources from illegal drugs in urban areas to illicit prescription drugs in rural areas in order to address the emerging opioid threat.”
• Temple pharmacology professor Robert Raffa: “The idea that your mom will go into a hospital, be exposed to morphine, and automatically become an addict is just plain wrong.”
• Professor David Brushwood: “Five years ago, if law enforcement saw a problem beginning to develop… they would very early on go to the doctor or pharmacist and say, ‘We think there’s a problem here.’ By the same token, physicians or pharmacists felt comfortable calling law enforcement and saying, ‘Something strange is going on. Come help us out.’ It was a culture of the early consult. The early consult is gone.”

Conclusion:

Libby’s analysis paints a concerning picture of the DEA’s crackdown on prescription painkillers. He argues that the agency’s actions are driven by unfounded fears, flawed data, and a self-serving financial structure, and ultimately result in the denial of essential medical care to millions of pain patients.

THE LIBBY REPORT ARGUMENT

FAQ: The DEA’s War on Prescription Painkillers

1. What is the main issue discussed in the source?

The source, “Treating Doctors as Drug Dealers: The DEA’s War on Prescription Painkillers”, criticizes the Drug Enforcement Administration’s (DEA) aggressive crackdown on physicians who prescribe opioid painkillers. The author argues that this approach has created a climate of fear among doctors, leading to the undertreatment of pain for millions of Americans while doing little to address the root causes of prescription drug abuse.

2. Why is the DEA targeting doctors who prescribe painkillers?

The DEA argues that a small group of doctors is overprescribing painkillers, leading to a rise in addiction and diversion to the black market. Facing criticism for its perceived ineffectiveness in reducing the illegal drug supply, the DEA shifted its focus to prescription drugs, viewing doctors as easier targets compared to illicit drug dealers.

3. What is the evidence for an “OxyContin epidemic”?

The DEA’s claims of an “OxyContin epidemic” are based on flawed data and questionable methodology. The agency’s criteria for “OxyContin-related deaths” are broad, often attributing deaths to OxyContin based on mere presence of the drug without conclusive evidence of causation. Furthermore, the DEA fails to account for the significant number of OxyContin tablets that are stolen or diverted through channels other than doctors’ prescriptions.

4. How has the media contributed to the problem?

The media has largely accepted and amplified the DEA’s narrative about the dangers of prescription painkillers, often using sensationalistic language and failing to provide balanced reporting. This has contributed to public fear and misunderstanding about the legitimate medical use of opioids for pain management.

5. What are the consequences of the DEA’s crackdown for pain patients?

The DEA’s actions have made it increasingly difficult for legitimate pain patients to access the medication they need. Doctors, fearing investigation and prosecution, are reluctant to prescribe opioids, even to patients with severe chronic pain. This has left many patients suffering needlessly or resorting to dangerous alternatives.

6. How does the DEA investigate doctors suspected of overprescribing?

The DEA uses a “red flag” system to identify doctors for investigation. However, these red flags are often subjective and based on circumstantial evidence, leading to investigations of legitimate physicians. The agency employs aggressive tactics like surveillance, undercover agents posing as patients, and reviewing billing practices, creating an adversarial relationship with the medical community.

7. Is there a difference between physical dependence and addiction?

Yes, pain specialists make a critical distinction between physical dependence and addiction. Patients taking opioids for pain management may develop physical dependence, meaning their body requires the medication to function normally. However, this is distinct from addiction, which is characterized by compulsive drug-seeking behavior and harmful consequences. The DEA often fails to recognize this difference, leading to the misclassification of pain patients as addicts.

8. What are some solutions to the issues presented in the source?

The source advocates for several policy changes, including:

• Clearer guidelines and evidentiary standards for DEA investigations of physicians.
• Increased education and training for law enforcement officials on the legitimate medical use of opioids.
• Protection for pain patients from prosecution and harassment.
• Reform of asset forfeiture laws to prevent the abuse of power by law enforcement.
• Increased funding for research and development of alternative pain management therapies.

Ultimately, a more balanced and compassionate approach is needed to address the complex issue of prescription drug abuse while ensuring that legitimate pain patients have access to the care they need.

Treating Doctors Like Drug Dealers: A Study Guide

Short-Answer Quiz

Instructions: Answer the following questions in 2-3 sentences each.

1. What is the main argument presented in Ronald T. Libby’s policy analysis?
2. What is the historical significance of the Harrison Act of 1914 in the context of pain management and law enforcement?
3. How did the DEA’s mission shift in the late 1990s and early 2000s? What factors contributed to this change?
4. Explain the flaws in the DEA’s methodology for classifying “OxyContin-related deaths,” as highlighted by Libby.
5. Describe the “drug hysteria” surrounding OxyContin and how the media played a role in shaping public perception.
6. What is the difference between “physical dependence” and “addiction,” and why is this distinction important in the discussion of pain management?
7. How does the DEA’s Diversion Control Program operate, and what concerns does Libby raise about its funding mechanism?
8. What are some of the “red flags” used by investigators to identify potential criminal behavior in physicians prescribing painkillers? What criticisms does Libby offer regarding this system?
9. How have the DEA’s investigative procedures impacted the doctor-patient relationship? Provide specific examples.
10. What are some of the potential consequences of the government’s crackdown on pain doctors, according to Libby?

Answer Key

1. Libby argues that the government’s aggressive pursuit of pain doctors for alleged overprescribing of painkillers is unjustified and harmful, leading to the undertreatment of pain and creating a climate of fear among physicians. He draws parallels to the Harrison Act of 1914, highlighting the historical precedent of criminalizing medical professionals for treating addiction.
2. The Harrison Act of 1914 criminalized the nonmedical use of opium, morphine, and cocaine, effectively turning addicts and the doctors who treated them into criminals. This law set a precedent for the government’s intervention in the doctor-patient relationship, particularly in the context of prescribing narcotics.
3. The DEA’s mission shifted from primarily focusing on illegal black market drugs to combating the diversion of prescription painkillers. This change was driven by Congressional criticism of the DEA’s effectiveness in reducing drug supply and the agency’s need to demonstrate measurable results in the “War on Drugs.”
4. Libby points out that the DEA’s criteria for “OxyContin-related deaths” are overly broad and lack scientific rigor. They often rely on the mere presence of oxycodone in a deceased person’s system or anecdotal evidence, failing to establish a definitive causal link between OxyContin and the death.
5. The media often uncritically repeated the DEA’s claims about the dangers of OxyContin, sensationalizing its abuse and contributing to a climate of fear and misinformation. Headlines like “The ‘Poor Man’s Heroin'” and anecdotal stories about addiction fueled public anxieties, leading to pressure on lawmakers and law enforcement to crack down on prescription painkillers.
6. Physical dependence refers to the body’s physiological adaptation to a drug, leading to withdrawal symptoms upon cessation. Addiction, on the other hand, involves compulsive drug-seeking behavior and a loss of control despite negative consequences. This distinction is crucial because pain patients can develop physical dependence on opioids without being addicted, meaning they require the medication to manage their pain without experiencing the harmful psychological and social effects of addiction.
7. The DEA’s Diversion Control Program is largely self-financed through licensing fees paid by doctors and pharmaceutical companies, as well as asset seizures from individuals suspected of drug diversion. Libby raises concerns about this system, arguing that it creates a conflict of interest where doctors are essentially funding investigations that may target them or their colleagues and that it lacks transparency and accountability.
8. Some “red flags” used by investigators include long patient wait times, patients traveling from out of state, short patient visits, and doctors prescribing high doses of narcotics. Libby criticizes this system as being subjective and based on circumstantial evidence that can be easily misinterpreted by those lacking medical training. He argues that these “red flags” often conflate legitimate pain management practices with criminal behavior.
9. The DEA’s aggressive investigative procedures have eroded trust between doctors and patients. Pain patients fear being viewed as addicts or being pressured to testify against their doctors, while doctors may become overly cautious and undertreat pain to avoid scrutiny from law enforcement. This chilling effect creates an adversarial environment where open communication and effective pain management are compromised.
10. Libby argues that the crackdown on pain doctors has led to an increase in the undertreatment of pain, forcing patients to suffer needlessly and potentially driving them to seek relief through illicit means. It has also created a climate of fear among physicians, discouraging them from specializing in pain management and potentially leading to a shortage of qualified practitioners in this critical field.

Essay Questions

1. Analyze the ethical implications of the government’s involvement in pain management, particularly the use of law enforcement tactics to regulate the prescribing practices of physicians.
2. Evaluate the role of the media in shaping public perception and policy decisions regarding the use of prescription painkillers. To what extent has media coverage contributed to the “drug hysteria” surrounding opioids?
3. Discuss the challenges of balancing the legitimate medical use of opioids for pain management with the need to prevent diversion and abuse. Consider the perspectives of patients, physicians, and law enforcement agencies.
4. Critically examine the effectiveness of the DEA’s Diversion Control Program in achieving its stated goals. Does the program’s emphasis on enforcement and asset forfeiture outweigh its potential negative consequences?
5. Explore the potential solutions for addressing the undertreatment of pain while simultaneously mitigating the risks associated with opioid prescribing. Consider the role of education, policy reform, and alternative pain management approaches.

Glossary of Key Terms

• Chronic Pain: Pain that persists for six months or longer.
• Acute Pain: Pain that is typically short-lived and results from an injury, surgery, or illness.
• Opioids: A class of drugs that relieve pain by interacting with opioid receptors in the brain and spinal cord. Examples include morphine, oxycodone, and hydrocodone.
• OxyContin: A brand name for a long-acting oxycodone medication used to treat moderate to severe pain.
• Harrison Act of 1914: A federal law that criminalized the nonmedical use of opium, morphine, and cocaine, effectively turning addicts and the doctors who treated them into criminals.
• Drug Enforcement Agency (DEA): The federal agency responsible for enforcing the controlled substances laws and regulations of the United States.
• Controlled Substances Act (CSA): A federal law that regulates the manufacture, distribution, and dispensing of controlled substances, including narcotics.
• Diversion: The illegal channeling of prescription drugs from legal sources to the black market.
• Asset Forfeiture: A legal process that allows law enforcement agencies to seize property that is believed to be connected to criminal activity.
• Red Flags: Indicators used by investigators to identify potential criminal behavior, such as suspicious prescribing patterns or patient characteristics.
• Physical Dependence: A physiological adaptation to a drug that can lead to withdrawal symptoms upon cessation.
• Addiction: A chronic, relapsing brain disease characterized by compulsive drug-seeking behavior and a loss of control despite negative consequences.
• Pseudoaddiction: A term used to describe behaviors that mimic addiction but are driven by inadequate pain relief rather than a primary desire for the drug’s effects.
• Intractable Pain: Pain that is resistant to treatment and significantly impacts an individual’s quality of life.